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Citizen Petitions

Foster Swift Collins & Smith

A Guide to Regulating Petition Circulators: Best Practices and Key Considerations

Petition circulators play a crucial role in democratic processes, but managing their activities can be challenging for public entities. Balancing petitioners' rights with the need to maintain public order and access to...more

Shook, Hardy & Bacon L.L.P.

Valisure Files Citizen Petition on Alleged Benzene in Benzoyl Peroxide, Triggering Lawsuits

Independent laboratory Valisure filed a March 5, 2024, citizen petition (CP) asserting, based on its own testing, that a number of benzoyl peroxide products contain high levels of benzene and that benzene concentrations are...more

Epstein Becker & Green

Unpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic

Epstein Becker & Green on

Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more

Harris Beach PLLC

Highlights from USCIS’ Proposed Rule to “Modernize” H-1B Requirements

Harris Beach PLLC on

The U.S. Department of Homeland Security (DHS) recently released a notice of proposed rulemaking (NPRM) entitled, “Modernizing H-1B Requirements, Providing Flexibility in the F-1 Program, and Program Improvements Affecting...more

Epstein Becker & Green

Unpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions

Epstein Becker & Green on

This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions.  Make no mistake, I have an interest in this...more

ArentFox Schiff

FDA Reaffirms It Will Not Prohibit Use of Certain Phthalates as Food-Contact Substances

ArentFox Schiff on

On July 21, 2023, the US Food and Drug Administration (FDA) issued a letter denying a request that it reconsider its decision from May 2022 that it would not prohibit the use of eight phthalates as food-contact substances. At...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Mississippi Approves Medical Marijuana: What a Long, Strange Trip It’s Been

Rarely are we able to combine the Grateful Dead and Mississippi in the same sentence, but the band once said, what a long strange trip it’s been. In November 2020, Mississippi voters overwhelmingly approved Initiative...more

Hogan Lovells

FDA to Propose Acacia (Gum Arabic) as a Dietary Fiber

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (gum arabic) as a dietary fiber. As a result of the petition, FDA intends to propose to include acacia,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Aviation Gas/Clean Air Act: Friends of the Earth Petitions U.S. Environmental Protection Agency for Endangerment Finding

Earthjustice submitted an August 24th Petition to the United States Environmental Protection Agency (“EPA”) asking that it make an endangerment finding under Section 231 of the Clean Air Act in regards to aviation gasoline...more

Jackson Lewis P.C.

Loss Of Congressional District Dooms Mississippi’s Medical Marijuana Initiative

Jackson Lewis P.C. on

The Mississippi Supreme Court held on May 14, 2021 that a citizen initiative to legalize medical marijuana violated the Mississippi Constitution. The decision turned on the loss of a congressional district due to the 2000...more

Perkins Coie

Fifth Appellate District Agrees that Special Taxes Enacted by Initiative Do Not Require Two-Thirds Supermajority Vote.

Perkins Coie on

Another court of appeal has held that local special taxes adopted by a citizen-sponsored initiative do not require two-thirds voter approval. City of Fresno v. Fresno Building Healthy Communities, No. F080264. (5th Dist.,...more

Perkins Coie

CEQA Year in Review 2020

Perkins Coie on

A Summary of Published Appellate Opinions Involving the California Environmental Quality Act - Despite relatively few published opinions this year, there were significant appellate court rulings on a range of topics,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Boehringer Ingelheim Seeks to Redefine a Biosimilar’s “Strength”

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more

Goodwin

Boehringer Ingelheim Files Citizen Petition Urging FDA to Address “Strength” Definition for Biosimilars, Citing Concerns Over...

Goodwin on

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral...more

Proskauer - Minding Your Business

H.R. 4712: A “Narrowly Tailored” Obligation Under the Orphan Drug Act?

The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l September 2020 #2

The U.S. Food and Drug Administration (FDA) has released a proposed update to traceability recordkeeping requirements for foods considered “high risk” as sources of foodborne illness. The proposed rule would apply to entities...more

Hogan Lovells

Council for Responsible Nutrition Submits Citizen Petition Requesting FDA Rulemaking to Allow CBD and other Hemp-Derived...

Hogan Lovells on

The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...more

Harris Beach PLLC

USCIS Seeks Federal Funding to Avoid Employee Furloughs, Likely Further Petition Delays

Harris Beach PLLC on

U.S. Citizenship and Immigration Services (USCIS) recently announced that due to the decreased amount of petitions currently being filed, it is seeking federal funding of $1.2 billion to help offset the loss of revenue it...more

Best Best & Krieger LLP

New Election, Conflict of Interest, Firearm and Cannabis Laws

Part 1: California Laws Impacting Public Agencies for 2020 - How do the laws passed last year by California lawmakers impact how public agencies do business in the new year? In this annual Legal Alert series, Best Best &...more

Jones Day

Consumer Groups File Petition Urging the USDA to Change Meat Labeling Requirements

Jones Day on

For years, natural sources of nitrates and nitrites have been used to cure meats as an alternative to traditional synthetic sources. The United States Department of Agriculture ("USDA") requires companies that cure meats...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l November 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on Citizen Petitions and Stay of Action Petitions Subject to FDCA Section 505(q)

Introduction: Citizen Petitions in the News - Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more

Carlton Fields

Legislation Impacts Citizen Petitions for Florida Constitutional Amendments

Carlton Fields on

On Friday, June 7, 2019, Gov. Ron DeSantis signed House Bill 5 into law, introducing immediate changes to the process for citizens to propose amendments to the Florida Constitution....more

Snell & Wilmer

Utah Supreme Court Allows Citizens to Block Real Estate Development Project by Voter Referendum

Snell & Wilmer on

The Utah Supreme Court recently decided Baker v. Carlson, 2018 UT 59, which considered a developer’s ongoing effort to build a mixed-use, part-residential and part-commercial development on the site of the long-defunct...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2019 #4

LEGISLATION, REGULATIONS & STANDARDS - FDA to Hold CBD Public Hearings - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly said in a February 27, 2019, hearing before the House...more

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